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Preliminary Evaluation of CASTLE Barrier Prototype UK

This study has been terminated.
(Inability of site to recruit/enroll target population)
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01530087
First received: February 7, 2012
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.


Condition Intervention
Peristomal Skin Irritation
 Device: CASTLE barrier

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas

Further study details as provided by Hollister Incorporated:

Primary Outcome Measures:
  • Peristomal skin irritation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Security [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    wear time leakage barrier erosion


Enrollment: 3
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
subjects with ileostomy or colostomy Device: CASTLE barrier
Prototype barrier to be used in place of current two piece device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample of referral population meeting eligibility criteria

Criteria

Inclusion Criteria:

  • at least 18 years of age
  • has colostomy or ileostomy
  • current uses two piece tape bordered barrier
  • has mild to moderate peristomal skin irritation
  • cares for their stoma independently in the community
  • at least 3 months post-operative
  • provides informed consent

Exclusion Criteria:

  • has fistula on or near stoma
  • has been involved in stoma care study in the last 30 days
  • is pregnant or lactating (determined by interview only)
  • has existing medical condition that would compromise their participation or follow-up
  • currently uses convex ostomy products, paste and/or rings
  • is allergic to test barrier components
  • is undergoing chemo- or radiotherapy that may affect the interpretation of the results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530087

Locations
United Kingdom
York Teaching Hospital
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Hollister Incorporated
Investigators
Study Director: Richard Murahata, PhD Hollister Incorporated
  More Information

No publications provided

Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01530087     History of Changes
Other Study ID Numbers: 4518-O, CIV-GB-11-07-001241
Study First Received: February 7, 2012
Last Updated: September 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hollister Incorporated:
colostomy
ileostomy
peristomal skin condition
two piece barrier

ClinicalTrials.gov processed this record on May 16, 2013